Product code LFH— Clinical Toxicology

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA

Classification name
U.V. Spectrometry, Tricyclic Antidepressant Drugs
Device class
Class 2
Regulation
21 CFR 862.3910
Advisory panel
Clinical Toxicology
Total cleared
6
First cleared
Most recent

Market context for product code LFH

FDA has cleared 6 devices under product code LFH between 1995 and 2023, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code LFH

Recent clearances under product code LFH

Data sourced from openFDA. This site is unofficial and independent of the FDA.